Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 36349 

[FR Doc. 2011–15466 Filed 6–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0474; FRL–8877–1] 

Diethylene Glycol MonoEthyl Ether 

(DEGEE); Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of Diethylene 

Glycol MonoEthyl Ether (DEGEE) when 

used as an inert ingredient as a solvent, 

stabilizer and/or antifreeze within 

pesticide formulations/products, for 

preharvest use on growing crops and 

raw agricultural commodities, without 

limitation. Huntsman, Dow 

AgroSciences L.L.C., Nufarm Americas 

Inc., BASF, Stepan Company, Loveland 

Products Inc., and Rhodia Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of DEGEE 

on growing crops and raw agricultural 

commodities. 

DATES: This regulation is effective June 

22, 2011. Objections and requests for 

hearings must be received on or before 

August 22, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0474. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0474 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 22, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2008–0474, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of July 9, 2008 

(73 FR 39291) (FRL–8371–2), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

8E7355) by Huntsman, 10003 Woodloch 

Forest Drive, The Woodlands, TX 

77380; Dow AgroSciences L.L.C., 9330 

Zionsville Road, Indianapolis, Indiana 

46268; Nufarm Americas Inc., 150 

Harvester Drive, Suite 220, Burr Ridge, 

Illinois, 60527; BASF, 26 Davis Drive, 

Research Triangle Park, NC 27709; 

Stepan Company, 22 W. Frontage Road, 

Northfield, IL 60093; Loveland Products 

Inc., PO Box 1286, Greeley, CO 80632; 

and Rhodia Inc., CN 1500, Cranbury, 

New Jersey, 08512. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of DEGEE (CAS Reg. No. 111– 

90–0) when used as an inert ingredient, 

as a solvent, stabilizer and/or antifreeze 


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36350 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 

in pesticide formulations applied to 

growing crops and raw agricultural 

commodities pre-harvest without 

limitation. That notice referenced a 

summary of the petition prepared by 

Huntsman, Dow AgroSciences L.L.C., 

Nufarm Americas Inc., BASF, Stepan 

Company, Loveland Products Inc., and 

Rhodia Inc., the petitioners, which is 

available in the docket, http:// 

www.regulations.gov. The Agency 

received one comment in response to 

the notice of filing. 

Currently, there is a tolerance 

exemption for DEGEE under 40 CFR 

180.920 when it is used as a deactivator 

for formulations used before the crops 

emerge from the soil and stabilizer. This 

document provides an assessment of the 

risk to human health and the 

environment for DEGEE when used as a 

pesticide inert ingredient as a solvent, 

stabilizer and/or antifreeze within 

pesticide formulations/products without 

limitation. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * * ’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for DEGEE including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with DEGEE follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by DEGEE as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The following toxicity data on DEGEE 

were summarized from these sources, 

the World Health Organization (WHO), 

National Toxicology Program (NTP), 

Hazardous Substances Data Base 

(HSDB) and BIBRA Toxicology 

Advisory and Consulting (1976, 2003, 

respectively). DEGEE has low acute 

toxicity via oral and dermal routes. It is 

moderately irritating to the skin and is 

mildly irritating to the eye. It is not a 

skin sensitizer. 

Several subchronic studies with 

DEGEE were available in rodents, ferrets 

and pigs. In rodents, toxicity was 

primarily manifested in the kidneys and 

liver. Increased kidney weights, tubular 

dilatation and centrilobular hepatocyte 

enlargement were seen at doses > 2,500 

milligrams/kilogram/day (mg/kg/day). 

In ferrets, effects in the kidney were also 

observed. The concentrating power of 

the kidney was decreased and water 

intake was decreased at > 2.0 milliliter 

(mL)/kg/day (2,240 mg/kg/day). Kidney 

and liver effects were also observed in 

pigs. Kidney weights were increased, 

tubular hydropic degeneration and 

enlarged centrilobular and midzonal 

hepatocytes with pyknotic nuclei and 

fatty infiltration were observed at > 500 

mg/kg/day. 

A subchronic inhalation study with 

DEGEE in the rat was also available. No 

effects were observed at doses up to 1.1 

milligrams/liter (mg/L) (approximately 

314 mg/kg/day). 

Several chronic carcinogenicity 

studies with DEGEE were available in 

rodents. However, these studies were 

conducted with a limited number of 

animals and doses and a complete 

histopathological examination was not 

performed. Due to these deficiencies, a 

definitive conclusion regarding 

carcinogenicity of DEGEE cannot be 

made on the basis of these studies. 

However, there were no obvious tumors 

detected in mice and rats. 

Developmental studies with DEGEE in 

rodents were available for review. Fetal 

susceptibility was not observed in these 

studies. Parental (mortality and reduced 

body weight) and offspring (reduced 

mean pup birth weight) toxicity were 

observed in mice at the high dose (2,500 

mg/kg/day). In a developmental toxicity 

study in rats via the dermal route of 

exposure, maternal toxicity was 

manifested as decreased body weight at 

6,615 mg/kg/day. Developmental 

toxicity was not observed at this dose. 

In an inhalation developmental toxicity 

study in rats, maternal and 

developmental toxicity were not 

observed up to 100 parts per million 

(ppm) (approximately 31 mg/kg/day). 

Two reproduction toxicity studies 

were available for review with DEGEE 

in rodents. One study in rats reported 

that increased urinary protein, bladder 

calculi, epithelial necrosis of the renal 


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tubules and cloudy swelling of hepatic 

tissue were observed in all animals at 

920 mg/kg/day of DEGEE with less than 

0.2% of ethylene glycol. The NOAEL in 

this study was 200 mg/kg/day. In 

another study in mice, offspring toxicity 

(decreased live pup weights, decreased 

absolute brain and liver weights) and 

parental toxicity (increase water intake 

and decreased body weight in males) 

occurred at 2,500 mg/kg/day. There 

were no effects on reproductive 

parameters in either study. 

Several mutagenicity studies (Ames 

test, micronucleus assay and 

unscheduled DNA synthesis) with 

DEGEE were available for review. One 

Ames test reported ambiguous results, 

another reported positive results at high 

doses. However, in vivo assays 

(micronucleus and unscheduled DNA 

synthesis) reported negative results. 

Therefore, based on the weight of 

evidence, DEGEE is not considered 

mutagenic. 

As noted, available long-term 

carcinogenicity studies were considered 

inadequate to fully assess DEGEE’s 

potential to cause cancer; however, 

these studies in mice and rats do not 

report any tumors. DEGEE belongs to 

the glycol ether class of chemicals 

which include structurally similar 

chemicals ethylene glycol (EG) and 

diethylene glycol (DEG). EG and DEG 

have toxicities similar to DEGEE. Target 

organs of toxicity are the kidney and 

liver. There was no evidence of 

carcinogenicity in rats and mice when 

treated with EG (NTP). Bladder tumors 

were observed in rats treated with DEG 

at >1,500 mg/kg/day, however, these 

tumors were secondary to irritation from 

bladder stones. The resulting 

classification for EG and DEG was that 

they are not expected to pose a 

carcinogenic risk in humans. Therefore, 

the carcinogenicity data on EG and DEG 

were used to assess the cancer potential 

of DEGEE. Based on the lack of evidence 

of carcinogenicity potential for EG and 

DEG, lack of tumors in mice and rats 

with DEGEE, and the fact that DEGEE is 

not mutagenic, DEGEE is not expected 

to be carcinogenic to humans. Also, the 

established chronic reference dose/ 

chronic population adjusted dose (cRfD/ 

cPAD) (2.0 mg/kg/day) for DEGEE will 

be protective of effects leading to kidney 

damage and tumor formation seen at 

>1,500 mg/kg/day following DEG 

exposures. 

Immunotoxicity studies for DEGEE 

were not available for review. However, 

DEGEE belongs to the glycol ethers class 

of chemicals. Immunotoxicity studies 

were available for ethylene glycol mono 

butyl ether (DEGBE), also a glycol ether 

differing in only one ethyl and butyl 

group from DEGEE. These data were 

used to assess the immunotoxic 

potential of DEGEE. Signs of potential 

immunotoxicity were not observed in 

any of the available studies for the 

surrogate chemical. Nor was there 

evidence of immunotoxicity potential in 

any of the studies submitted for DEGEE. 

Therefore, DEGEE is not expected to be 

immunotoxic. 

Dermal absorption studies were 

available with DEGEE. In a study using 

human epidermal membranes, the 

absorption rate of DEGEE was 0.206 mg/ 

cm2/hr. 

The available metabolism data in an 

adult human revealed that 68% of the 

administered dose of DEGEE was 

excreted in the urine as (2-ethoxy) acetic 

acid. In a metabolism study in the 

rabbit, oral or subcutaneous exposure to 

DEGEE resulted in the excretion of 

glucuronic acid in the urine; the major 

part of the dose was oxidized. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for DEGEE used for human 

risk assessment is shown in the 

following table. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DEGEE FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary general population 

including Females 13–50 years 

of age.

An acute endpoint was not identified in the database. 

Chronic dietary (All populations) .... NOAEL = 200 mg/kg/day .............

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

Chronic RfD = 2.0 mg/kg/day 

cPAD = 2.0 mg/kg/day.

Reproduction Toxicity Study with 

chronic/ carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DEGEE FOR USE IN HUMAN RISK ASSESSMENT— 

Continued 

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Incidental oral short-term (1 to 30 

days).

NOAEL= 200 mg/kg/day ...............

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Incidental oral intermediate-term (1 

to 6 months).

NOAEL= 200 mg/kg/day ...............

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Dermal short-term (1 to 30 days) .. NOAEL= 200 mg/kg/day (dermal 

absorption rate = 25%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Dermal intermediate-term (1 to 6 

months).

NOAEL= 200 mg/kg/day (dermal 

absorption rate = 25% when 

appropriate).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) study NOAEL= 

200 mg/kg/day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Inhalation (1 to 6 months) .............. Inhalation (or oral) study NOAEL 

= 200 mg/kg/day (inhalation absorption rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 ..................... Reproduction Toxicity Study with 

chronic/carcinogenicity measurements—rat LOAEL = 920 

mg/kg bw/day, based on decreased growth, epithelial necrosis of renal tubules and 

cloudy swelling of hepatic tissue. 

Cancer (Oral, dermal, inhalation) .. Based on the lack of tumors in a study with DEGEE and carcinogenicity data available for the structurally 

similar chemicals, EG and DEG, and that DEGEE is not mutagenic, DEGEE is not expected to be carcinogenic to humans. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference 

dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to DEGEE, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

DEGEE in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

DEGEE were seen in the toxicity 

databases. Therefore, an acute dietary 

exposure assessment for DEGEE is not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 


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Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, no residue data were submitted 

for DEGEE. In the absence of specific 

residue data, EPA has developed an 

approach which uses surrogate 

information to derive upper bound 

exposure estimates for the subject inert 

ingredient. Upper bound exposure 

estimates are based on the highest 

tolerance for a given commodity from a 

list of high use insecticides, herbicides, 

and fungicides. A complete description 

of the general approach taken to assess 

inert ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts,’’ (D361707, 

S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest levels of tolerances would 

be no higher than the concentration of 

the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. Further, pesticide 

products rarely have a single inert 

ingredient; rather there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

in relation to that of the active 

ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. As discussed above, the 

Agency has not identified any concerns 

for carcinogenicity relating to DEGEE, 

and, therefore, a dietary exposure 

assessment to assess cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for DEGEE, a 

conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

DEGEE may be used in inert 

ingredients in products that are 

registered for specific uses that may 

result in residential exposure. A 

screening level residential exposure and 

risk assessment was completed for 

products containing DEGEE as inert 

ingredients. The Agency selected 

representative scenarios, based on enduse product application methods and 

labeled application rates. The Agency 

conducted an assessment to represent 

worst-case residential exposure by 

assessing DEGEE in pesticide 

formulations (Outdoor Scenarios) and 

DEGEE in disinfectant-type uses (Indoor 

Scenarios). The Agency is not aware of 

any use of DEGEE in hard surface 

cleaning products. However, this 

scenario was used for this assessment 

considering wide use of DEGEE in other 

products. Therefore, the Agency 

assessed the disinfectant-type products 

containing DEGEE using exposure 

scenarios used by the Antimicrobials 

Division in EPA’s Office of Pesticide 

Programs to represent worst-case 

residential handler exposure. Further 

details of this residential exposure and 

risk analysis can be found at http:// 

www.regulations.gov in the 

memorandum entitled: ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations,’’ (D364751, 5/7/09, 

Lloyd/LaMay in docket ID number 

EPA–HQ–OPP–2008–0710. 

In addition to pesticidal uses for 

DEGEE, there are non-pesticidal uses for 

DEGEE. However, dermal and 

inhalation exposure are expected to be 

negligible; therefore, a quantitative 

exposure assessment was not 

conducted. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found DEGEE to share a 

common mechanism of toxicity with 

any other substances, and DEGEE does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that DEGEE 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 


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evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Fetal susceptibility was not observed in 

the developmental toxicity studies with 

DEGEE in the mouse. Developmental 

studies were available via the oral 

(mice), dermal (rats) and inhalation 

(rats) routes of exposure in rodents. 

Following oral exposure to DEGEE, 

maternal (mortality and reduced body 

weight) and offspring (reduced mean 

pup birth weight) toxicity were 

observed in mice at the high dose (2,500 

mg/kg/day). Following dermal exposure 

to DEGEE, maternal toxicity was 

manifested as decreased body weight at 

6,615 mg/kg/day in rats. Developmental 

toxicity was not observed at this dose. 

Following inhalation exposure to 

DEGEE, maternal and developmental 

toxicity were not observed up to 100 

ppm (approximately 31 mg/kg/day) in 

rats. A developmental toxicity study in 

rabbits is not available in the database. 

However, the concern for the lack of this 

study is low because toxicity was 

observed near the limit dose in the 

developmental and reproduction studies 

in rodents (>920 mg/kg/day). 

Evidence of increased fetal 

susceptibility was observed in a 

reproduction toxicity study in the mice. 

Offspring toxicity was manifested as 

decreased adjusted live pup weight and 

absolute brain weights and increased 

liver weights in the absence of parental 

toxicity. There is no concern for this 

increased susceptibility in mice because 

these pup effects were observed at a 

dose 2.5 times above the limit dose of 

1,000 mg/kg/day and a clear NOAEL 

was established in the study. It is 

unclear if there is fetal susceptibility in 

the reproduction toxicity study in rats. 

In this study, it was stated that 

increased urinary protein, bladder 

calculi, epithelial necrosis of the renal 

tubules and cloudy swelling of hepatic 

tissue were observed in all animals at 

920 mg/kg/day (NOAEL 200 mg/kg/ 

day). It is not clear whether all animals 

referred in the study include both the 

parental and F1 animals or not. 

However, in any case the concern for 

fetal susceptibility is low because the 

aforementioned effects occured near the 

limit dose and the cRfD (2.0 mg/kg/day) 

will be protective of these effects. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for DEGEE is 

adequate for FQPA assessment. The 

following acceptable studies are 

available: Developmental and 

reproduction toxicity studies in mice 

and rats, subchronic and mutagenicity 

studies. A 2-generation reproduction 

toxicity study where tumors were 

evaluated is available. Also, chronic/ 

carcinogenicity studies are available on 

a surrogate chemical, ethylene glycol. A 

developmental toxicity study in rabbits 

is not available in the database. 

However, the concern for the lack of this 

study is low because toxicity was 

observed at or above the limit dose in 

the developmental and reproduction 

studies in rodents. 

ii. Signs of neurotoxicity were not 

observed in a reproduction toxicity 

study in rats. Decreased absolute brain 

weights were observed in the offspring 

at 2,500 mg/kg/day. However, a 

developmental neurotoxicity study is 

not required because decreased brain 

weights were observed above the limit 

dose (1,000 mg/kg/day), the effect 

occurred in the presence of maternal 

toxicity and the cRfD (2.0 mg/kg/day) 

will be protective of this effect. 

Therefore, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is evidence that DEGEE 

results in increased fetal susceptibility 

in the multi-generation reproduction 

study in the mouse. However, the 

concern for fetal susceptibility is low 

because the effects seen in the offspring 

(adjusted live pup weight and absolute 

brain weights and increased liver 

weights) occur at 2,500 mg/kg/day 

(2.5times the limit dose), the effects 

occur in the absence of maternal 

toxicity, a clear NOAEL (1,250 mg/kg/ 

day) was established and the cRfD (2.0 

mg/kg/day) will be protective of these 

effects. 

iv. Immunotoxicity studies for DEGEE 

were not available for review. However, 

DEGEE belongs to the glycol ethers class 

of chemicals. Immunotoxicity studies 

were available for ethylene glycol 

monobutyl ether, also a glycol ether. 

This data were used to assess the 

immunotoxic potential of DEGEE. Signs 

of potential immunotoxicity were not 

observed in any of the available studies 

for the surrogate chemical. Nor was 

there evidence of immunotoxicity 

potential in any of the studies submitted 

for DEGEE. Therefore, DEGEE is not 

expected to be immunotoxic. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% crop 

treated (CT) and tolerance-level 

residues. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to DEGEE in drinking 

water. EPA used similarly conservative 

assumptions to assess postapplication 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by DEGEE. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, DEGEE is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to DEGEE from 

food and water will utilize 0.10% of the 

cPAD for the general U.S. population 

and 0.31% of the cPAD for children 1 

to 2 years old, the population group 

receiving the greatest exposure. Based 

on the explanation in this unit, 

regarding residential use patterns, 

chronic residential exposure to residues 

of DEGEE is not expected. 


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3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

DEGEE is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

DEGEE. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 264 for both adult males and 

females, respectively. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

homeowner mixer/loader/applicators 

using a trigger sprayer with a high end 

post application dermal exposure from 

contact with treated lawns. As the level 

of concern is for MOEs that are lower 

than 100, this MOE is not of concern. 

EPA has concluded that the combined 

short-term aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 228 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for DEGEE is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

DEGEE is currently used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to DEGEE. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate MOEs of 777 for adult 

males and females. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

homeowner mixer/loader/applicators 

using a trigger sprayer with a high end 

post application dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 267 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). Because EPA’s level 

of concern for DEGEE is a MOE of 100 

or below, these MOEs are not of 

concern. 

5. Aggregate cancer risk for U.S. 

population. DEGEE is not expected to 

pose a carcinogenic risk in humans 

based on the discussion in Unit IV.A. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to DEGEE 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for DEGEE. 

C. Response to Comments 

The comment was received from 

private citizens who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA) EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

the statute. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for DEGEE (CAS 

Reg. No. 111–90–0) when used as an 

inert ingredient (as a solvent, stabilizer 

and/or antifreeze within pesticide 

formulations/products without 

limitation) in pesticide formulations 

applied to growing crops and raw 

agricultural commodities pre-harvest. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from tolerance under section 

408(d) of FFDCA in response to a 

petition submitted to the Agency. The 

Office of Management and Budget 

(OMB) has exempted these types of 

actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 


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the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 10, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Diethylene Glycol MonoEthyl Ether (CAS Reg. No. 111– 

90–0).

Without limitation ................ Solvent, stabilizer and/or antifreeze. 

* * * * * * * 

[FR Doc. 2011–15266 Filed 6–21–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0517; FRL–8876–2] 

C9 Rich Aromatic Hydrocarbons, 

C10–11 Rich Aromatic Hydrocarbons, 

and C11–12 Rich Aromatic 

Hydrocarbons; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of C9 rich 

aromatic hydrocarbons; C10–11 rich 

aromatic hydrocarbons; and C11–12 rich 

aromatic hydrocarbons, when used as 

inert ingredients in pesticide 

formulations applied to growing crops 

or to raw agricultural commodities after 

harvest. ExxonMobil Chemical 

Company submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of C9 rich 

aromatic hydrocarbons, C10–11 rich 

aromatic hydrocarbons, and C11–12 rich 

aromatic hydrocarbons. 

DATES: This regulation is effective June 

22, 2011. Objections and requests for 

hearings must be received on or before 

August 22, 2011, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2011–0517. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 


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